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class=\"wp-block-paragraph\">\u627f\u8a8d\u306e\u4f55\u5e74\u3082\u524d\u304b\u3089\u3001\u65e5\u672c\u306e\u5b66\u4f1a\u306e\u69cb\u9020\u3092\u7406\u89e3\u3057\u3066\u3044\u305f\u3002\u8ab0\u304c\u610f\u601d\u6c7a\u5b9a\u3092\u3057\u3066\u3044\u308b\u304b\u3001\u305d\u306e\u4eba\u9593\u306e\u7acb\u5834\u304c\u4eca\u5f8c\u3069\u3046\u5909\u308f\u308b\u304b\u3092\u898b\u636e\u3048\u3066\u3044\u305f\u3002\u305d\u3057\u3066\u305d\u306e\u4e0a\u3067\u3001\u88fd\u54c1\u306e\u627f\u8a8d\u7533\u8acb\u3068\u5b66\u4f1a\u3078\u306e\u50cd\u304d\u304b\u3051\u3092\u4e26\u8d70\u3055\u305b\u3066\u3044\u305f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9006\u306b\u5931\u6557\u3057\u305f\u30d1\u30bf\u30fc\u30f3\u3082\u4e00\u8cab\u3057\u3066\u3044\u307e\u3059\u3002\u512a\u308c\u305f\u88fd\u54c1\u3092\u6301\u3061\u3001\u627f\u8a8d\u3082\u53d6\u308c\u305f\u3002\u3057\u304b\u3057\u5b66\u4f1a\u3068\u306e\u9023\u643a\u3092\u5f8c\u56de\u3057\u306b\u3057\u3001\u4fdd\u967a\u53ce\u8f09\u3068\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u58c1\u306b\u6c17\u3065\u3044\u305f\u3068\u304d\u306b\u306f\u624b\u9045\u308c\u3060\u3063\u305f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u300c\u306a\u305c\u6210\u529f\u3057\u3001\u306a\u305c\u5931\u6557\u3059\u308b\u306e\u304b\u300d\u306e\u69cb\u9020\u3092\u77e5\u308b\u3053\u3068\u304c\u3001\u65e5\u672c\u5e02\u5834\u53c2\u5165\u306e\u8a2d\u8a08\u56f3\u3092\u63cf\u304f\u51fa\u767a\u70b9\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u6b21\u56de\u4e88\u544a<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b21\u56de\u306f**\u300c\u65b0\u898f\u4fdd\u967a\u53ce\u8f09\u306e\u898b\u3048\u306a\u3044\u58c1\u2500\u2500\u306a\u305c\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u5916\u90e8\u304b\u3089\u898b\u3048\u306a\u3044\u306e\u304b\u300d**\u3092\u30c6\u30fc\u30de\u306b\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e2\u5b58\u88fd\u54c1\u3068\u65b0\u898f\u88fd\u54c1\u3067\u4f55\u304c\u6839\u672c\u7684\u306b\u9055\u3046\u306e\u304b\u3002\u4fdd\u967a\u53ce\u8f09\u306b\u81f3\u308b\u307e\u3067\u306e\u9593\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u3089\u306a\u3044\u3068\u3053\u308d\u3067\u4f55\u304c\u8d77\u304d\u3066\u3044\u308b\u306e\u304b\u3002\u305d\u3057\u3066\u3001\u306a\u305c\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u5916\u90e8\u304b\u3089\u307b\u3068\u3093\u3069\u898b\u3048\u306a\u3044\u306e\u304b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u5168\u4f53\u50cf\u3092\u6574\u7406\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3053\u306e\u554f\u984c\u306f\u3001\u5fa1\u793e\u3067\u3082\u8d77\u304d\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u300c\u627f\u8a8d\u3092\u53d6\u3063\u305f\u306e\u306b\u58f2\u308c\u306a\u3044\u300d\u300c\u672c\u793e\u306b\u8aac\u660e\u304c\u901a\u3089\u306a\u3044\u300d\u300c\u5b66\u4f1a\u3068\u306e\u95a2\u4fc2\u3092\u3069\u3053\u304b\u3089\u4f5c\u308c\u3070\u3044\u3044\u304b\u308f\u304b\u3089\u306a\u3044\u300d\u2014\u2014\u305d\u3046\u3057\u305f\u8ab2\u984c\u3092\u304a\u6301\u3061\u306e\u65b9\u306f\u3001\u307e\u305a\u304a\u8a71\u3057\u304f\u3060\u3055\u3044\u3002\u521d\u56de60\u5206\u3001\u7121\u6599\u3067\u304a\u53d7\u3051\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"http:\/\/seiei-bp.com\/#s13\">\u7121\u6599\u76f8\u8ac7\u3092\u7533\u3057\u8fbc\u3080\uff08\uff16\uff10\u5206\uff09<\/a><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">\u3088\u308a\u6df1\u304f\u77e5\u308a\u305f\u3044\u65b9\u3078\uff1a\u672c\u30b7\u30ea\u30fc\u30ba\u306f\u516831\u672c\uff08\u6709\u6599\uff09\u3067\u3001\u4fdd\u967a\u53ce\u8f09\u306e\u5b9f\u614b\u30fb\u5b66\u4f1a\u69cb\u9020\u306e\u8aad\u307f\u65b9\u30fbKOL\u9023\u643a\u30fbDTC\u8a2d\u8a08\u30fb\u4ee3\u7406\u5e97\u9078\u629e\u30fb\u672c\u793e\u6298\u885d\u307e\u3067\u300131\u5e74\u306e\u5b9f\u52d9\u7d4c\u9a13\u304b\u3089\u3057\u304b\u66f8\u3051\u306a\u3044\u30ce\u30a6\u30cf\u30a6\u3092\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u2192 <a href=\"https:\/\/note.com\/seijisaito\" data-type=\"link\" data-id=\"https:\/\/note.com\/seijisaito\">Note\u30de\u30ac\u30b8\u30f3\u3092\u898b\u308b<\/a><\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<h3 class=\"wp-block-heading\">\u8457\u8005\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u9f4b\u85e4\u8aa0\u53f8<\/strong> <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8aa0\u6804\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u30ba\u682a\u5f0f\u4f1a\u793e \u4ee3\u8868\u53d6\u7de0\u5f79<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5916\u8cc7\u7cfb\u30d8\u30eb\u30b9\u30b1\u30a2\u30fb\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306e31\u5e74\u4ee5\u4e0a\u306e\u5b9f\u52d9\u7d4c\u9a13\u3092\u6301\u3064\u3002\u30d2\u30eb\u30ed\u30e0\u30fb\u30b8\u30e3\u30d1\u30f3\u3067\u65e5\u672c\u30fb\u97d3\u56fd\u4ee3\u8868\u3068\u3057\u3066\u5728\u4efb\u671f\u9593\u4e2d\u306b\u65e5\u672c\u4e8b\u696d\u5e74\u5e73\u5747\u6210\u9577\u7387\uff08CAGR\uff09+27%\u3092\u9054\u6210\u3002\u65e5\u672c\u30b3\u30af\u30ec\u30a2\u3067\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u8cac\u4efb\u8005\u3068\u3057\u3066\u5e02\u5834\u30b7\u30a7\u30a2+18pt\u3092\u5b9f\u73fe\u30022026\u5e744\u6708\u306b\u8aa0\u6804\u30d3\u30b8\u30cd\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u30ba\u682a\u5f0f\u4f1a\u793e\u3092\u8a2d\u7acb\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4fdd\u6709\u8cc7\u683c\uff1a\u4e2d\u5c0f\u4f01\u696d\u8a3a\u65ad\u58eb\u30fb\u884c\u653f\u66f8\u58eb\u30fbAFP\u30fb\u60c5\u5831\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30fbExecutive MBA\uff08\u540d\u53e4\u5c4b\u5546\u79d1\u5927\u5b66\u5927\u5b66\u9662\uff09<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"http:\/\/seiei-bp.com\/wp-content\/uploads\/2026\/04\/Profile_saitoseiji-1024x1024.jpg\" alt=\"\u9f4b\u85e4\u8aa0\u53f8\" class=\"wp-image-43\"\/><\/figure>\n<\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u00a9 Seiei Business Partners Co., Ltd.\u7121\u65ad\u8ee2\u8f09\u3092\u7981\u3058\u307e\u3059\u3002<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The Three Barriers Foreign Healthcare Companies Face When Entering Japan<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Barrier 1: Winning or Losing the Japan Market is Decided Before Filing for Approval<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Author: Seiji Saito (Representative Director, Seiei Business Partners Co., Ltd. \/ Registered Management Consultant &amp; Certified Legal Specialist)<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u201cWe obtained regulatory approval, so why isn&#8217;t it selling?\u201d<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Local subsidiaries of foreign healthcare companies often receive this inquiry from their global headquarters. From headquarters&#8217; perspective, the logic seems simple: regulatory approval equals market readiness. Therefore, they wonder why revenue is not growing. However, the reality I have repeatedly witnessed over more than 31 years of hands-on experience is entirely different.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>In the Japanese market, obtaining regulatory approval is merely a prerequisite to get to the starting line. Whether a company can clear the hurdles that lie beyond depends heavily on the steps taken before the approval application process even begins.<\/strong> This article outlines that structure.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Three Barriers Await After Approval<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">After obtaining approval for medical devices or in vitro diagnostics under the PMD Act (Pharmaceuticals and Medical Devices Act) in Japan, there are three major hurdles before a product is actually used in clinical settings.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">1. The Reimbursement Barrier<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">In Japan, the vast majority of medical expenses are covered by public health insurance. Products that are not reimbursed present a significantly lower incentive for medical institutions to adopt them. However, reimbursement is a completely separate process from PMD Act approval. There is a major divergence here that many foreign companies overlook: the process for a product that fits into an existing category is fundamentally different from that for a new category. For the latter, highly sophisticated logical framing is required to prove clinical and economic utility during price negotiations.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">2. The Facility Criteria and Notification Barrier<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Even if a product receives reimbursement coverage, it cannot be used immediately at any hospital. In many cases, specific &#8220;facility criteria&#8221; are established. Only medical institutions that meet conditions such as &#8220;having a physician on staff who has performed a certain number of cases&#8221; or &#8220;maintaining specific equipment and systems&#8221; and have completed notifications to the Regional Bureau of Health and Welfare can claim insurance reimbursement for using that medical device.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">3. The Medical Society Guideline Barrier<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">In Japanese medicine, clinical guidelines issued by medical societies hold absolute influence. No matter how much approval and insurance coverage a product receives, if it is not listed as a &#8220;recommended&#8221; option in the medical society guidelines, it is extremely rare for conservative Japanese physicians to proactively adopt a new treatment or device on their own.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pre-Approval Strategic Design Dictates Everything<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It is too late to start thinking about countermeasures for these three barriers after approval is obtained.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example, the battle has already begun at the stage of <strong>\u201cwhat kind of clinical trial data should be acquired.\u201d<\/strong> Data sufficient to secure PMD Act approval (proof of safety and efficacy) is often insufficient for favorable price calculation in reimbursement (proof of utility) or for achieving a high recommendation level in medical society guidelines.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Long before filing an approval application, a company must map out its reimbursement scenario, initiate dialogue with key opinion leaders (KOLs) and medical societies, and design a roadmap for evidence generation toward guideline inclusion. This is the true &#8220;frontline-driven&#8221; strategy for successful market entry in Japan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If you are facing challenges such as \u201cnot understanding Japan\u2019s regulations, commercial distribution channels, or medical society structures\u201d or \u201cstruggling to explain and convince global headquarters,\u201d please feel free to reach out. The first 60-minute consultation is complimentary.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"http:\/\/seiei-bp.com\/#s13\"><strong>Book a Free Consultation (60 min)<\/strong><\/a><\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><em>For those who want to go deeper, this series covers the realities of reimbursement, how to read Japan\u2019s medical society landscape, KOL engagement, DTC strategy, distributor selection, and communication with global headquarters \u2014 all from a perspective grounded in more than 31 years of frontline experience.<\/em><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About the Author<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Seiji Saito<\/strong> Seiei Business Partners Co., Ltd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Representative Director<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Seiji Saito has more than 31 years of frontline experience in foreign-capital healthcare and medical device businesses in Japan. As head of Japan and Korea at Hill-Rom Japan, he achieved a +27% CAGR in the Japan business during his tenure. As Marketing Director at Cochlear Japan, he increased market share by 18 percentage points. In April 2026, he founded Seiei Business Partners Co., Ltd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Credentials: METI-Registered Management Consultant \/ MIC-Certified Legal Specialist \/ AFP (AFFILIATED FINANCIAL PLANNER\u00ae) \/ Information Security Management \/ Executive MBA, NUCB (Nagoya University of Commerce and Business)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u00a9 2026 Seiei Business Partners Co., Ltd. All rights reserved.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u58c1\u2460\uff1a\u627f\u8a8d\u7533\u8acb\u306e\u524d\u306b\u6c7a\u307e\u308b\u3001\u65e5\u672c\u5e02\u5834\u306e\u52dd\u6557 \u300c\u627f\u8a8d\u3092\u53d6\u3063\u305f\u306e\u306b\u3001\u306a\u305c\u58f2\u308c\u306a\u3044\u306e\u304b\u300d \u5916\u8cc7\u7cfb\u30d8\u30eb\u30b9\u30b1\u30a2\u4f01\u696d\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u672c\u793e\u2026<\/p>\n","protected":false},"author":4,"featured_media":41,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-1","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-column"],"_links":{"self":[{"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/posts\/1","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1"}],"version-history":[{"count":11,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/posts\/1\/revisions"}],"predecessor-version":[{"id":64,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/posts\/1\/revisions\/64"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=\/wp\/v2\/media\/41"}],"wp:attachment":[{"href":"https:\/\/seiei-bp.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/seiei-bp.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}